Manufacturer registered with FDA
Chamfond Biotech Co., Ltd
Nanjing, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 616 registrations outside the US
- Establishments
- 1China
Registered in 6 markets
Where regulators' registries name Chamfond Biotech Co., Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Chamfond Biotech Co., Ltd | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Chamfond Biotech Co.,Ltd | 6 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CHAMFOND BIOTECH CO., LTD. | 4 | 2022–2023 | Pure Global AI |
| Australia | TGA | Manufacturer | Chamfond Biotech Co Ltd | 3 | 2023–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Chamfond Biotech Co., Ltd. | 2 | 2024–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | CHAMFOND BIOTECH CO., LTD. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Chamfond Biotech Co., Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Maker | Headlight | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CHAMFOND BIOTECH CO., LTD.FDA reg. 3015532203 | Nanjing Jiangsu, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060786). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.